Responsibilities: Resolution of fundamental Computer System Validation compliance issues on assigned projects. Writing, reviewing, and executing computer validation documentation. Perform computer system validation activities related to process control systems of pharmaceutical water for injection system, water pretreatment system, water stills and high-quality steam generation systems. Validation of computerized systems, in accordance with GAMP5 and V-Model (USR, Function Specification, IQ/OQ/Protocol/Report/Testing, Traceability Matrix, Validation Report). ssessing electronic/paper records aiming to identify Data Integrity gaps with Risk-Based Approach to suggest the most appropriate mitigation/remediation actions. Ensuring that all project-related issues and deviations are recorded, approved and dispensed accordingly. Preparation of project and life-cycle reports and review/approve all other documents to ensure compliance with SOP. Ensuring that all project and lifecycle documents achieve the goal of traceability, and are all retained in the document repository (Document Navigator) and approved following the prescribed SOP. Requirements: t least 8 years s of experience in the pharmaceuticals field, with focus on Computer System Validation. Previous work experience in computer system validation of PLC's, HMI's, SCADA and historian. Experienced in computer system validation of Rockwell Factory Talk, Microsoft SQL Server, Microsoft NET Framework and Allen Bradley PLC systems preferably related to process control systems. bility to perform input and output testing. Strong understanding of FDA regulations for commissioning, validation, and lifecycle management of GMP equipment and process control systems. Strong knowledge in good documentation practices. Knowledge of Data Integrity Assurance according to EU GMP Annex1, US FDA Annex 11. Knowledge of regulations and guidelines applicable to computerized and automated systems (GAMP, 21 CFR part 11). Katalyst Healthcares and Life Sciences
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We are looking for good pathology MTs who can work evenings. Must reside in the U.S. or Canada. Our MTs are independent contractors working from home. For more information regarding earning potential, equipment needed, and the reports we transcribe. Please email us for...
Do you thrive in a dynamic and innovative work environment? If so, we invite you to consider joining the team! Our client specializes in designing and manufacturing high-performance components and systems for a wide range of applications across industries such as aerospace...
...Travel PercentageNoneJob CategoryPharmacyDescriptionThe Healix Infusion Therapy... ...USP 800. The pharmacy provides sterile compounded medications for Healix-managed infusion... ...Responsibilities of the Compounding Pharmacy Technician:Include the following. Other duties...